Preprints are all around us – but are they relevant and useful or too risky for industry-sponsored research? Two sessions at the 14th Annual Meeting of ISMPP in Washington this month kicked off the first major public discussions on preprints in our medical communications community.
Preprints are publicly available copies of manuscripts that are shared before peer review and publication. They are common practice in physics and other quantitative fields, with over one million preprints now hosted on arXiv. Preprints are becoming increasingly prevalent in biological sciences, with 24 000 preprints now on bioRxiv, hosted by Cold Spring Harbor Laboratory. With extra ethical issues to be considered for medical research, the Yale University Open Data Access (YODA) Project is now developing MedRxiv.
The medical communications community supporting the publication of pharmaceutical research has not yet engaged significantly in preprints. With the growing popularity of preprints outside pharma, bolstered by a policy mandating preprints for all research supported by the Chan Zuckerberg Initiative, the International Society for Medical Publication Professionals (ISMPP) recognized that the time was right to discuss preprints at their Annual Meeting in May 2018.
Richard Sever, co-founder of bioRxiv, presented a history of preprints, their benefits and growth, and some thinking points specific to medical research. Discussions opened between the expert panel members, who then took questions from the audience. Taking part were:
- Brian Falcone, Executive Vice President at Oxford PharmaGenesis Inc, moderating
- Richard Sever, Assistant Director of Cold Spring Harbor Laboratory Press and co-founder of bioRxiv
- Jonathan Druhan, Global Publications Director at AstraZeneca
- Joseph Ross, Associate Professor of Medicine and Public Health at Yale University, by phone
What are the benefits of preprints?
- With some papers taking years to be published in full, preprints make results available in a timely fashion
- Demonstrating ownership of research at the earliest possible stage helps to avoid the potential for reviewers to trump work before this is published
- The scientific community can read and comment on preprints, meaning that authors can then improve their manuscripts before submission to a journal – however, most bioRxiv preprints do not attract comments and most preprints are not revised on bioRxiv, as shown by Heather Lang’s research – see
- The bioRxiv preprint server includes a function that allows easy submission of manuscripts directly from bioRxiv to the journal
- Readers can build on research more quickly and ultimately speed up the overall progress of scientific knowledge
- Scientists want to know the latest research developments, as they do through congress presentations and posters – could preprints be considered in some respects similar to congress materials?
- A preprint can be cited as a reference and tracked with its own DOI, and Crossref has recently created a category of DOIs specifically for preprints in order to reduce confusion with peer-reviewed articles
What are the potential problems for pharma, and how could we address them?
- Journalists or internal pharma staff may misuse information in preprints by citing it as if it was from a peer-reviewed source
- Preprints need to have a bold disclaimer and watermark, possibly more prominently than they currently do on bioRxiv
- Do preprints sacrifice quality for speed?
- bioRxiv does not use a high-screening threshold; authors are unlikely to want to show low-quality material in public
- PLoS has preprint editors, which could improve quality
- Predatory publishers may trawl preprints to attract submissions
- Preprint comments sections may attract trolls
- Comments are public and named
- There may be lots of noise for authors to filter
- Preprints may be used as citation for false arguments; the citation of non-peer-reviewed sources may be harmful to patients
- Peer review is not a guarantee of quality, demonstrated by a recent article on acupuncture published in PLOS ONE and subsequent controversy, which could have been avoided through comments on preprints before submission to a journal
- Do preprints count as safe harbour, legitimate scientific exchange in the way that peer-reviewed articles do?
- Basic science and early research and development work is low-risk, but as a pharmaceutical product approaches a New Drug Application, companies become more risk-averse
- It is not yet clear what the governmental or regulatory policy will be
- Could preprints be used to disseminate results without peer-reviewed publication?
- Preprints are not intended to substitute for peer review or journal editorial processes
- As an author service, it would be hard for a preprint server to enforce a time frame for full publication; however, old preprints not published in full could attract comments
The ISMPP audience’s view
A live audience poll at the end of the panel session highlighted a big gap between what the audience would like to see – preprints for human clinical development studies except the pivotal study – and what they perceive as the reality of what is currently possible – preprints for preclinical and basic science work only.
Industry involvement in preprints
In the afternoon, Heather Lang of Oxford PharmaGenesis presented her analysis of the uptake of preprints by the top 50 pharmaceutical companies.
- Preprints are already being used by the industry
- Approximately 1% reported industry-authored research
- Half of the top 50 companies were represented, and corresponding authors were affiliated to 10/50 companies
- Nearly all preprints were on basic science, with bioinformatics and genomics as the top fields, although results of a phase 2 study have also been reported
- Some degree of scientific exchange is taking place
- Other bioRxiv users commented on 7% of industry-authored preprints
- The authors responded in two-thirds of cases
- One-third of industry-authored preprints were revised after they were first posted, a similar proportion to the rest of bioRxiv
- Most of the research has now been published in peer-reviewed journals
- More industry-authored preprints (68%) posted for at least a year had been fully published than the rest of bioRxiv (55%)
Preprints are helping basic science manuscripts involving the pharmaceutical industry to be disseminated more quickly, without displacing the standard peer review model. With MedRxiv in development, there may soon be more preprints reporting clinical research – and from discussions at ISMPP, we, as members of the medical communications sector, need wider education and open discussion about preprints. It may well be time to evaluate the appropriateness of posting different types of research as preprints, to consider running pilots to explore the use of preprint servers, and to develop and communicate policies on appropriate preprint use.
From 2017 and through 2018, the Open Pharma project has been bringing together pharma publications leaders, senior publishers and experts in various topics (including preprints), and we plan to continue taking part in and facilitating this conversation. We may develop educational materials on preprints, so we would be glad to hear what you need.
References and resources
Heather’s slides are available without restriction here: https://doi.org/10.21305/ismppus2018.002
ISMPP members can access slides from the sessions at the ISMPP archive here: http://www.ismpp.org/annual-meeting
An explanation of bioRxiv and MedRxiv from John Inglis of Cold Spring Harbor Laboratory is free to access here: https://www.slideshare.net/BaltimoreNISO/inglis-preprints-in-biology-and-medicine
bioRxiv is free for anyone to access, so to see an example of a preprint, why not read and comment on our preprint on open access policies of high-impact journals here: https://www.biorxiv.org/content/early/2018/01/22/250613
MedRxiv is being developed by the YODA Project at Yale University: http://yoda.yale.edu/medrxiv/